Theraworx pre-moistened cloths

Theraworx pre-moistened cloths

Drug Labeling and Warnings

Drug Details

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THERAWORX PRE-MOISTENED CLOTHS - allantoin liquid 
Avadim Technologies, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Theraworx pre-moistened cloths

Theraworx pre-moistened cloths


Active Ingredient:

Allantoin 0.5%

Purpose

Skin Protectant

Uses:

  • For temporary Protection of minor cuts, scrapes, burns, and chapped or cracked skin.

Warning:

  • For external use only.

Keep out of reach of children.


Do not use in the eyes.

  • Do not use on deep or puncture wounds, animal bites, or serious burns.
  • Extended use may increase risk of sunburn.

Stop use and ask doctor

if condition worsens or symptoms last more than seven days.

Directions:

Cleanse with either side of the cloth allowing skin to air dry. No rinse needed. DO NOT FLUSH

Inactive Ingredients:

Purified Water, Aloe, Citrus Based Preservative, Cocamidopropyl Betaine, Colloidal Silver, Lauryl Glucoside, Beta Glucan, Dimethicone, Methyl Paraben, Propyl Paraben, EDTA, Fragrance, Vitamin E

Theraworx pre-moistened cloths 2 count (61594-000-00)| Theraworx pre-moistened cloths 8 count (61594-000-01)

Representative Labeling


Cloth Front

Cloth Back

THERAWORX PRE-MOISTENED CLOTHS 
allantoin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61594-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SILVER (UNII: 3M4G523W1G)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETIC ACID (UNII: 9G34HU7RV0)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61594-000-0035 g in 1 POUCH
2NDC: 61594-000-01140 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/13/2014
Labeler - Avadim Technologies, Inc. (041443877)
Establishment
NameAddressID/FEIBusiness Operations
Avadim Technologies, Inc.041443877manufacture(61594-000)

Revised: 3/2014
 
Avadim Technologies, Inc.


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